Use of the LEVA® Pelvic Health System for Fecal Incontinence

NCT06152224 | Active Not Recruiting Phase 4 Results DMC FDA Device

• 4 other identifiers: 2023-1304A532810Protocol Version 10/1/2024SMPH/OBGYN BENIGN GYN
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn about how the duration of use of The Leva Pelvic Health System® affects treatment of fecal incontinence in women. The main question it aims to answer is to test whether use of the The Leva Pelvic Health System® for 8 weeks is as good as using it for 16 weeks. Participants will complete surveys, and use the Leva device.

Conditions

Fecal Incontinence

Keywords

anal incontinence; accidental bowel leakage; pelvic health system

Outcome Measures

Primary Outcomes (1)

• Vaizey Score to Compare Effectiveness of Improving Fecal Incontinence Between 8 Weeks and 16 Weeks of Use

  Treatment response as length of use on symptom improvement at 16 weeks (comparing 8 weeks vs 16 weeks of use of Leva) as assessed by Vaizey Score, score ranges from 0-24, higher scores indicate more severe symptoms. A difference of -4.3 ± 3 is expected at 8 weeks and 16 weeks (compared to baseline), with an allowable difference of 1.

  Baseline to 16 weeks

Secondary Outcomes (18)

• Change in Fecal Incontinence Severity

  Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years

• Cumulative Adherence Correlation With Change in St. Mark's Score

  Baseline to 24 weeks, long term follow up at 1 and 2 years

• Patient Satisfaction and Usability of the Smartphone Application Component of the Leva Pelvic Health System

  Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years

• Change in Fecal Incontinence From Baseline to 24 Weeks After 8 or 16 Weeks of Treatment

  Baseline to 24 weeks, long term follow up at 1 and 2 years

• Change in Pelvic Organ Prolapse Quantification System (POP-Q)

  Baseline to 16 weeks

Study Arms (2)

8 week use of Leva

EXPERIMENTAL

Device: The Leva Pelvic Health System

16 week use of Leva

ACTIVE COMPARATOR

Device: The Leva Pelvic Health System

Interventions

The Leva Pelvic Health System DEVICE

The Leva Pelvic Health System includes an intra-vaginal device that pairs with a smartphone application to provide real-time visual feedback about pelvic floor muscle performance during usage.

16 week use of Leva; 8 week use of Leva

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult, age ≥ 18years, assigned female at birth
• Fecal incontinence, defined as any uncontrolled loss of liquid or solid fecal material that occurs at least monthly over the last 3 months that is bothersome enough to desire treatment
• Able to stand to perform daily training for at least 3 minutes
• Able to speak and read English due to Leva smartphone application availability in only English at this time
• Have an email address, owns a smartphone, and can download an app

You may not qualify if:

• Inability to tolerate insertion of vaginal device (e.g., vaginal agenesis, vaginal stenosis, unremitting pelvic pain, within 12 weeks postpartum)
• Current diagnosis of colorectal or anal malignancy
• Diagnosis of uncontrolled inflammatory bowel disease
• Current rectovaginal fistula or cloacal defect
• Rectal prolapse (mucosal or full thickness)
• Inability to utilize smart phone technology ("app" use)
• Chronic Stool Types 6 or 7
• Fecal impaction by exam
• Stage 4 pelvic organ prolapse
• Concurrent supervised anal sphincter exercise/pelvic floor muscle training with or without biofeedback
• Presence of sacral neuromodulator
• Pelvic floor surgery (including anal sphincteroplasty) within the past 3 months
• Currently pregnant

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Fecal Incontinence; Encopresis

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Results Point of Contact

• Title: Ushma Patel, MD
• Organization: UW School of Medicine and Public Health

upatel@uwhealth.org

(608) 287-5898

Study Officials

• Dobie Giles, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: November 30, 2023
• Study Start: January 17, 2024
• Primary Completion: December 17, 2024
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 30, 2025
• Results First Posted: May 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)